Observational Study of MRI for Hip Replacement Complications
This study is looking at how Magnetic Resonance Imaging (MRI) can help doctors detect problems with total hip replacements. Specifically, it aims to see if MRI can find early "adverse local tissue reactions" (ALTRs), which are issues caused by wear debris from the implant, even before you feel symptoms. It also investigates how well MRI can detect if an implant is becoming loose. You might be able to join if you have a total hip replacement with a ceramic component that needs revision, or if you have a metal-on-polyethylene hip replacement that has repeatedly dislocated or is over a year old. The study hopes to show that MRI can be a valuable tool for monitoring hip implant health and preventing more serious complications.
- Study design
- This is an observational study planning to enroll 240 participants. It is not specified whether it is randomized or blinded.
- What's involved
- You will have office visits at the start, then at 1, 2, and 3 years post-operatively for monitoring.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for an average of 1 year post-operatively for one endpoint, and for 3 years for another endpoint.
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Using MRI To Detect Soft Tissue Reactions And Implant Integration As Related To Implant Modularity
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Matthew F Koff, PhD · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York
- Hollis G Potter, MD · PRINCIPAL_INVESTIGATOR · Hospital for Special Surgery, New York
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Utilize MRI to evaluate total hip arthroplasty designs traditionally not implicated with the presence of adverse local tissue reactions.An expected average of 1 year post-operatively
All enrolled arthroplasty designs will be evaluated utilizing the input of: 1. Evaluation of MR images: Presence, location, type and volume of synovitis, Synovial thickness, Impression of synovium, Presence and location of decompression of synovitis, Presence and location of low signal intensity deposits, Presence of soft tissue edema, Presence and location of dehiscence, Presence, location and volume of osteolysis, Assessment of implant loosening, Presence of and location of neurovascular compression, Disruption of abductors due to distended pseudocapsule, Presence of enlarged lymph nodes and presence and grading of adverse local tissue reaction. 2. Pre-operative blood metal ion levels 3. Pre-operative Hip disability and Osteoarthritis Outcome Score 4. Pathologic evaluation of tissue obtained intra-operatively 5. Intra-operative grade of soft tissues around the primary total hip replacement 6. Implant wear analysis
- Longitudinal monitor of arthroplasty loosening in patients with different individual risk factors and implant bearing surfaces and characteristicsThis outcome will be measured at 4 different time points: Initial office visit, 1 year follow-up, 2 year follow-up, 3 year follow-up.
All enrolled arthroplasty designs will be evaluated utilizing the input of: 1. The formation a fibrous membrane and/or osteolysis around the implants 2. Individual risk factors from subjects (gender, BMI, primary diagnosis, and level of activity) 3. Individual risk factors based on implant characteristics (stem length, head size, and modular stem connections).